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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

An inspection of China Food and Drug Administration (CFDA) by the country’s anti-corruption agency has led to the publication of a litany of alleged failings at the regulator. The graft group is calling for CFDA to standardize its review, approval and inspection processes to eliminate the “many loopholes” and examples of “dereliction of duty” identified during its assessment of the drug regulator.

The Central Commission for Discipline Inspection (CCDI), the top-ranking internal-control unit of the Communist Party of China, sent its inspection teams into CFDA earlier this year. In a public statement to outline its findings, CCDI provided few concrete details and examples of the failings it identified during its inspection. Instead, the agency, which has become an increasingly powerful force since Xi Jinping became head of the Communist Party, released a list of vague but significant criticisms of the food and drug regulator and its leaders.

Among the list of criticisms are points that question the ability of CFDA to regulate the drug industry in China. CCDI inspectors discovered “many loopholes” when assessing the regulator's operation. The anti-corruption also brought up concerns with regulatory capacity. While some of these issues are largely beyond CFDA’s control — its capacity, for example, is tied to its budget — the regulator is more liable for some of the others cited by CCDI. The lack of clarity regarding who is responsible for what and the excess of discretion allowed to enforcement officers are issues for which CFDA is answerable.

Some of the other criticisms are to do with the extent to which CFDA has adopted and implemented ways of thinking and working that are advocated by the Communist Party. For example, inspectors accused CFDA of paying too little attention to “party building,” a term CCDI and the government use to describe activities designed to bolster the Communist Party. CCDI also noted perceived flaws with the hiring and education processes at CFDA, shortcomings that the anti-corruption agency sees as enabling unsuitable people to obtain and retain positions within the organization.

Exactly what happens now is unclear. Leading officials have promised to resolve the issues and take steps to ensure the organization complies with anti-corruption rules, but the CCDI is light on details regarding what this will entail.

DCGI Seeks Feedback on Plan to Phase out use of Rabbits in Eye Irritation Testing

The Drug Controller General of India (DCGI) is seeking feedback on a proposal to phase out the use of rabbits to evaluate the risk drugs and other products will cause eye irritation. DCGI Dr. GN Singh put out the request following a meeting to discuss the topic, at which participants questioned the ability of preclinical testing laboratories in India to transition to alternative methods.

Use of the method, dubbed Draize test after its inventor, has caused controversy around the world for years, in part because of doubts about whether it is necessary and effective. The formation of the committee in India to evaluate the use of the test is, in part, a reaction to the debates that these doubts have led to around the world. The United States Food and Drug Administration has moved away from requiring Draize test data without ever publishing guidance on the topic, while recent guidelines in Europe have given the industry some flexibility in the choice of ocular toxicity test.

In response to these trends, Indian regulators have set about reassessing their own practices. The request for feedback from Singh acknowledged the international trend away from the Draize test and animal testing in general, while questioning the readiness of India to make the transition. In particular, the committee wants more information on the preparedness of Indian preclinical testing laboratories to switch to alternatives and the extent to which such alternatives have been validated in the country.

The committee has doubts about whether the feedback it receives on these topics will be compelling enough to justify an immediate abandonment of the Draize test. As such, the committee is also seeking feedback on how long it will take India to equip itself to make the transition and what this process will entail. DCGI has given the industry two weeks to respond to the request.

CFDA has released a draft document detailing the process for end-of-Phase II meetings and other key regulatory communication events during drug development. The document is intended to establish a standardized process and timeline for communication between the Chinese regulator and companies advancing drugs toward approval in the country.

In proposing the communication process, CFDA has split up the different types of meetings between itself and drug developers into three categories. The categories cover meetings to address significant issues in the advance of breakthrough therapies, critical stages in clinical development of innovative drugs and questions regarding generics. CFDA is proposing the shortest communication timelines for breakthrough therapies, which it categorizes as class I meetings, and the longest for meetings about generic products and other matters it deems less time-sensitive.

For many developers of innovative drugs, the category between these two extremes, class II, will be of the most significance. In the section on class II meetings, CFDA details when during the clinical trial process it wants to meet with drug developers. The communication timeline borrows from the model followed by other regulators. CFDA is keen to meet with drug developers to discuss their data prior to the start of Phase I and following the end of Phase II. These points are when companies and CFDA must assess whether to advance into first-in-human trials and the design of pivotal clinical trials.

To help companies prepare for these and other meetings, CFDA has provided an overview of the materials they should provide and what they can expect to happen at the session. For example, CFDA recommends applicants provide a list of issues they want to discuss. The list should be split up into different categories, such as toxicology and clinical trial design, and include a brief overview of the work performed to date and the outstanding uncertainties. Such preparation increases the chances of the meeting addressing all of the issues within the 90-minute timeframe set by CFDA.

The Drug Regulatory Authority of Pakistan (DRAP) has released a standard operating procedure for the annual increase in the price of drugs in the country. DRAP is set to increase the cost of drugs next month for the first time since a policy was passed that capped prices at the levels of 2013.

That policy set June 2016 as the month in which Pakistan would next conduct an across-the-board reassessment of drug prices in the country. DRAP has released the document so companies are ready for the change. Within four days of the Pakistan Bureau of Statistics publishing the Consumer Price Index, which drug prices are tied to, a committee will release recommended rates of increases for different classes of products.

Since the price cap policy was passed last year, DRAP has become embroiled in an array of disputes as multinationals have raised prices and politicians have accused the regulator of colluding with companies to enable the increases. Some of the disputes have centered on the economic viability of selling medicines at prices that were set in 2013, an issue that may be partly addressed by the upcoming round of increases.